Active monitoring of scientific knowledge base. Scientific findings are reviewed and assessed as a foundation for characterizing new technologies.

Source : FDA

TRL 2 Development of Hypotheses and Experimental Designs

Scientific "paper studies" to generate research ideas, hypotheses, and experimental designs for addressing the related scientific issues. Focus on practical applications based on basic principles observed. Use of computer simulation or other virtual platforms to test hypotheses.

TRL 4 Candidate Optimization and Non-GLP In Vivo Demonstration of Activity and Efficacy

Integration of critical technologies for candidate development. Initiation of animal model development. Non-GLP in vivo toxicity and efficacy demonstration in accordance with the product's intended use. Initiation of experiments to identify markers, correlates of protection, assays, and endpoints for further non-clinical and clinical studies.

Animal Models: Initiate development of appropriate and relevant animal model(s) for the desired indications.

Assays: Initiate development of appropriate and relevant assays and associated reagents for the desired indications.

4C Initiate experiments to determine assays, parameters, surrogate markers, correlates of protection, and endpoints to be used during non-clinical and clinical studies to further evaluate and characterize candidate(s).

Source : FDA

TRL 5 Advanced Characterization of Candidate and Initiation of GMP Process Development

Animal Models: Continue development of animal models for efficacy and dose-ranging studies.

Assays: Initiate development of in-process assays and analytical methods for product characterization and release, including assessments of potency, purity, identity, strength, sterility, and quality as appropriate.

Manufacturing: Initiate process development for small-scale manufacturing amenable to GMP.

Target Product Profile: Draft preliminary Target Product Profile. Questions of shelf life, storage conditions, and packaging should be considered to ensure that anticipated use of the product is consistent with the intended use for which approval will be sought from FDA.

8B Prepare and submit New Drug Application (NDA) or Biologics Licensing Application (BLA) to the FDA.

8C Obtain FDA approval or licensure.

Source : FDA

TRL 9 Post-Licensure and Post-Approval Activities

9A Commence post-licensure/post-approval and Phase 4 studies (post-marketing commitments), such as safety surveillance, studies to support use in special populations, and clinical trials to confirm safety and efficacy as feasible and appropriate.